Pine Pharmaceuticals, LLC announced two voluntary recalls of multiple ophthalmic products, including bevacimuab 1.25 mg/0.05 mL, following a recent FDA inspection.
Let’s start with this company.
Founded in 1985 and based in Tonawanda, New York, the FDA-registered 503b outsourcing facility specializes in preparing high-quality, ready-to-administer compounds and repackaged products such as:
See here for a product list.
Now this recall.
Per two urgent product recalls (see here and here) posted on October 2, 2023, the company identified the affected products applying to certain lots that were collectively distributed from the facility between May 3, 2023, and September 29, 2023.
Talk about this FDA inspection.
The recall was initiated “due to an observation by the [FDA] of a potential lack of sterility assurance for products intended to be sterile, resultant from a step in the inspection process isolated to the affected batches,” according to Pine.
The routine inspection was conducted September 6-19, 2023.
What’s the risk?
The potential risk of administering drugs intended to be (but that are not) sterile could lead to serious infections and the possibility of vision loss.
Speaking of … have there been any reports of adverse events?
As of October 2, 2023, no. The same goes for any patient-related injuries to the sterility of the affected products.
So about these products—can I get some names?
In addition to repackaged bevacizumab, the drugs include (but are not limited to):
- Vancomycin (1 mg/0.1 mL)
- Moxifloxacin IN BSS 150 mcg/0.1 mL
- Cefuroxime 10 mg/mL
- TPC (Tropicamide / Phenylephrine / Cyclopentolate) Drops 1% - 2.5% - 1% 5 mL
See here and here for the complete list of affected products, including lot numbers and expiration dates.
What has the company done to handle the recall?
Pine has since shifted its production to product lines not impacted by the recall. Any select product shortages are expected to be temporary.
In the meantime however, the company is asking customers to order only one week’s supply at a time, but potential allocation limits may also be necessary.
Any specific products unavailable due to this?
According to the American Society of Retina Specialists (ASRS), “customers using item #987 (Norm-Ject Less Fill, silicone-free syringe) will need to choose a different syringe as the production of this product is temporarily unavailable due to process limitations.”
What should I do if a patient has been given these products?
Pine has provided instructions for returning these products (found here), which might require including a prepaid return label and a Recall Acknowledgement and Receipt Form.
And if I need to report an adverse event?
Complaints or adverse drug events linked to any of the affected products can be reported via quality@pinepharmaceuticals.com or calling 844-218-4138.
Seems like this has been the year of recalls.
You’re telling me.
Back in January 2023, the CDC called for an immediate discontinuation of EzriCare Artificial Tears (later followed by Delsam Pharma’s Artificial Tears and Artificial Eye Ointment) after reports of infections across the country.
To date, the CDC identified 81 people in 18 states with Pseudomonas aeruginosa, a type of bacterium that has historically demonstrated resistance to antibiotics.
The aftermath: Fourteen people went blind, four required enucleation, and four others died. Additionally, a mass of lawsuits have ensued.